Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

In this 2-year, multisite, randomized, placebo-controlled trial involving 607 children with vesicoureteral reflux that was diagnosed after a first or second febrile or symptomatic urinary tract infecton, we evaluated the efficacy of Trimethoprim-Sulfamethoxazole (TMP-SMZ) prophylaxis in preventing recurrences (primary outcome). Secondary outcomes were renal scarring, treatment failure (a composite of recurrences and scarring), and antimicrobial resistance.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Collaborator: University of North Carolina, Chapel Hill
• Treatments: Sulfamethoxazole; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination

Criteria

Inclusion Criteria:

• Age at randomization: at least 2 months, but less than 6 years of age. Note that children as young as 1 month were screened for the study.

• Diagnosed first or second febrile or symptomatic UTI within 112 days prior to randomization

• Presence of Grade I- IV VUR based on radiographic voiding cystourethrogram (VCUG) performed within 112 days of diagnosis of index UTI.

• Appropriately treated index febrile or symptomatic UTI

Exclusion Criteria:

• Index UTI diagnosis more than 112 days prior to randomization

• History of more than two UTIs prior to randomization

• For patients less than 6 months of age at randomization, gestational age less than 34 weeks

• Co-morbid urologic anomalies

• Hydronephrosis, SFU Grade 4

• Ureterocele

• Urethral valve

• Solitary kidney

• Profoundly decreased renal size unilaterally on ultrasound (based on 2 standard deviations below the mean for age and length) performed within 112 days after diagnosis of index UTI

• Multicystic dysplastic kidney

• Neurogenic bladder

• Pelvic kidney or fused kidney

• Known sulfa allergy, inadequate renal or hepatic function, Glucose-6-phosphate dehydrogenase deficiency or other conditions that are contraindications for use of TMP-SMZ

• History of other renal injury/disease

• Unable to complete the study protocol

• Congenital or acquired immunodeficiency

• Underlying anomalies or chronic diseases that could potentially interfere with response to therapy such as chronic gastrointestinal conditions (i.e., malabsorption, inflammatory bowel disease), liver or kidney failure, or malignancy.

• Complex cardiac disease as defined in the Manual of Procedures.

• Any known syndromes associated with VUR or bladder dysfunction

• Index UTI not successfully treated

• Unlikely to complete follow-up

• Family history of anaphylactic reaction to sulfa medications